The Role of Prior Art in Patent Law – Old and Admitted Prior Art
Despite the promulgation of the American Invents Act (AIA) in 2012, the concept of prior art has basically stayed the same. Section 102 embodies two different concepts. First, the concept of novelty embodies that there are things other people do to destroy the novelty of the patent applicant’s claimed invention. These include publishing the subject […]
The 505(b)(2) Application and the ANDA – Similarities and Differences
FDA’s 505(b)(2) Application The 505(b)(2) new drug application (NDA) is an attractive regulatory and commercial strategy for clients. This hybrid NDA application helps avoid duplicative and costly studies that others have already completed. FDA’s rules allow (b)(2) applicants to rely on this prior body of work. And because of this reliance, the (b)(2) development is […]
Understanding Product-By-Process Claims in Patent Law
Typical patent claims are to products or processes but not both. But product-by-process claims exist and have existed for decades. Plainly, the typical product-by-process claim is designed to claim a product when made by a particular process. It is a hybrid type of claim. But questions arise of how product-by-process claims are interpreted when considering […]
Skinny Label Lives – Section viii Carve-Out and Non-Infringement of Method of Treatment Patents
Back in August, the Federal Circuit’s GSK v. Teva opinion landed with quite a splash in the Hatch-Waxman world. In that case, Teva’s carvedilol “skinny label” (i.e. drug label with Section viii carve-out) did not serve to fend off a finding of induced infringement of a patent that claims the method of treatment that was […]
Upadhye Tang LLP – In Case You Missed It
Upadhye Tang LLP was founded a few years ago to focus on our core competencies: IP and FDA law. We know the life sciences business and clients trust us for our advice. And given the fierce competition, we are tough fighters for our clients. Let’s recap who we are and what we are about. We […]
The Role of Prosecution History (File Wrapper) in Patent Law
In patent litigation, most attorneys focus on the patent document itself. After all, the patent is being asserted in the litigation so it makes sense. But the patent document is not born in its final form. Rather, it starts as a patent application filed at the USPTO. The Examiner and applicant engage in the typical […]
Attorney Fee Awards in Patent Litigation
A lawsuit that goes to the bitter end will result in a winner and a loser. And with the win in hand, the winner then thinks it’s entitled to fees and costs as reimbursement. The typical situation in American court litigation is that everyone pays his or her own legal fees. This default standard is […]
A Lack of Essential Testing Method Parameter in Patent Claims Led to Indefiniteness, but Inequitable Conduct Is Hard to Prove – Lessons from Sun v. Lupin
In a recent District of New Jersey decision, Chief Judge Wolfson found a patent indefinite, obvious, and not infringed (due to a failure of proof). Sun Pharma v. Lupin, 2021 WL 4473411 (Sept. 30, 2021). However, the court did not find inequitable conduct by clear and convincing evidence, despite the inventor’s “hubris” and incorrect understanding […]
Inequitable Conduct Defense During Patent Litigation
in a 505(b)(2) NDA Context
The § 505(b)(2) regulatory pathway gives a smaller pharmaceutical company, a start-up company even, the opportunity to submit and obtain FDA approval of a new drug application (NDA) without breaking the bank. A 505(b)(2) NDA may rely heavily on data from an already-marketed drug product and information in published literature to demonstrate the safety and […]
IPR Estoppel – A Truly Double-Edged Sword
Since its creation by the America Invents Act of 2011, Inter Partes Review (or IPR) has been a valuable tool for current or future patent defendants. However, the risk/reward calculus has changed over the years since the IPR originated. In particular, the estoppel effects of an IPR decision are now a much more important consideration […]
